a retrospective real-world study on the efficacy and safety of anlotinib hydrochloride combined with immunotherapy maintenance therapy following standard chemoimmunotherapy for es-sclc (alter-l059)

Conditions: Small Cell Lung Cancer Extensive Stage

Summary: this retrospective real-world study aims to evaluate the efficacy and safety of anlotinib hydrochloride combined with immunotherapy as maintenance therapy following standard chemoimmunotherapy in extensive-stage small cell lung cancer (es-sclc).the study population consists of treatment-naïve es-sclc patients who did not progress after induction chemoimmunotherapy and subsequently received maintenance therapy with anlotinib plus immunotherapy. the primary objectives are progression-free survival (pfs)，overall survival (os) , and safety.

this multicenter study seeks to retrospectively analyze medical records (january 2022-december 2024) of extensive-stage small cell lung cancer (es-sclc) patients treated with anlotinib hydrochloride (12/10/8 mg doses) alongside immune maintenance therapy after first-line chemoimmunotherapy in real-world clinical settings. key data points will encompass demographics, baseline disease characteristics, treatment regimens, efficacy outcomes (e.g., objective response rate, progression-free survival), and adverse event profiles. eligible patients must have received anlotinib for ≥6 weeks and possess evaluable radiographic assessments. the primary objectives are to assess the clinical effectiveness and safety of this combination strategy in es-sclc.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged 18 years or older; 2. histologically or cytologically confirmed extensive-stage small cell lung cancer (es-sclc) (per the veterans administration lung study group \[valg\] staging criteria); 3. patients who previously received chemotherapy for limited-stage sclc must have undergone curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) and have a treatment-free interval of at least 6 months from the end of prior therapy (last chemotherapy cycle or radiotherapy) to the diagnosis of es-sclc; 4. at least one measurable target lesion (per recist version 1.1 criteria); 5. no disease progression after receiving 4-6 cycles of first-line chemoimmunotherapy induction therapy for es-sclc; 6. ecog performance status: 0-2; 7. life expectancy ≥3 months. exclusion criteria: 1. patients with limited-stage sclc who previously received chemotherapy and underwent curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) but experienced disease recurrence within 6 months after completion of prior therapy; 2. patients with limited-stage sclc who previously received immunotherapy agents (e.g., pd-1/pd-l1 inhibitors) or anti-angiogenic agents (e.g., anlotinib, apatinib, bevacizumab); 3. patients with extensive-stage small cell lung cancer (es-sclc) who developed disease progression during induction therapy with a standard chemoimmunotherapy regimen; 4. active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose; 5. patients with coagulation dysfunction, defined as an international normalized ratio (inr) \>1.5 or activated partial thromboplastin time (aptt) \>1.5 × upper limit of normal (uln), and/or those with a bleeding tendency; 6. patients deemed by the inves.